Accucuff Cuff Pressure Indicator
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- AccuCuff EUDAMEDMedis FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- Cuff Pressure Indicators EUDAMEDCuff pressure indicator, with Luer Lock, Red, Laryngeal FDA UDICuff Pressure indicator, with Luer Lock, Blue,Tracheal FDA UDI
- Model / Reference
- AC0100R EUDAMEDFDA UDIAC0100B EUDAMEDFDA UDIAC0100B，AC0100R，AC0100P EUDAMED
- Description
- Cuff pressure indicator, with Luer Lock, Red, Laryngeal FDA UDICuff Pressure indicator, with Luer Lock, Blue,Tracheal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06920687300887 EUDAMEDFDA UDI06920687300870 EUDAMEDFDA UDI
- Basic UDI-DI
- 69206873AC001EM EUDAMED
- 510(k) Number
- FDA Product Code
- BSK FDA 510(k)FDA UDI
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5750 FDA 510(k)
- Regulation Number
- 868.5750 FDA 510(k)FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Accucuff Cuff Pressure Indicator is a Cuff, Tracheal Tube, Inflatable, designed to monitor and display cuff pressure in tracheal tubes. It provides real-time feedback to ensure optimal inflation levels, reducing the risk of tracheal injury or airway complications during anesthesia procedures.
This device is intended for single-use in clinical settings, including operating rooms and intensive care units. Supplied sterile and classified as a Class II medical device under FDA regulations (510(k) clearance) and MDR compliance, it is compatible with various tracheal tube sizes. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality, with no specific MRI safety considerations noted.
Frequently asked questions
What is the primary purpose of the Accucuff Cuff Pressure Indicator in clinical settings?
The Accucuff Cuff Pressure Indicator is designed to monitor and display real-time cuff pressure in tracheal tubes during anesthesia procedures. This helps ensure optimal inflation levels, reducing the risk of tracheal injury or airway complications by providing immediate feedback to clinicians.
Is the Accucuff Cuff Pressure Indicator intended for single-use or reusable applications?
The Accucuff Cuff Pressure Indicator is explicitly intended for single-use in clinical environments like operating rooms and intensive care units. This design choice aligns with sterility requirements and best practices for patient safety.
How should the Accucuff Cuff Pressure Indicator be stored to maintain its functionality and sterility?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. While no specific MRI safety considerations are noted, adherence to standard sterile storage protocols—such as sealed packaging and protection from contamination—is critical to ensure proper performance.
What tracheal tube sizes is the Accucuff Cuff Pressure Indicator compatible with?
The Accucuff Cuff Pressure Indicator is compatible with various tracheal tube sizes, though exact dimensions are not specified in the provided data. Its design is intended to integrate with standard inflatable tracheal tube cuffs used in anesthesia procedures.
What regulatory pathways has the Accucuff Cuff Pressure Indicator followed for approval?
The device has undergone FDA 510(k) clearance (traditional pathway, classified as Class II) and complies with MDR (Medical Device Regulation) standards. The submission was reviewed by the FDA’s Anesthesiology Advisory Committee (AN) and deemed substantially equivalent to existing devices under product code BSK (Cuff, Tracheal Tube, Inflatable).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medis Medical, AccuCuff - Medis Medical, K182548 - Accucuff Cuff Pressure Indicator - Anesthesiology, Accucuff Cuff Pressure Indicator (K182548) — FDA 510 (k) | Innolitics, PDF Tianjin Medis Medical Device Co., Ltd. General Manager P.O. Box 120-119 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182548 | Class II | Active |
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Manufacturer
- Manufacturer
- Tianjin Medis Medical Device Co., Ltd.
Sources (5)
- FDA 510(k) K182548 24 fields · synced Oct 6, 2026
- FDA UDI 380be878-ffbd-4974-a161-c3f1f0bd7acb 35 fields · synced May 30, 2026
- FDA UDI ea63b4c2-59a1-4d3b-a763-f86516abdc91 35 fields · synced May 30, 2026
- EUDAMED fe5b0786-b030-4938-9ea0-2960145c1b05 61 fields · synced Jul 9, 2026
- EUDAMED 1b397657-ca5c-4770-a450-3e75608a73ac 61 fields · synced Jul 11, 2026